The following data is part of a premarket notification filed by Faico Medical Llc with the FDA for Faico Cmf System.
| Device ID | K191997 |
| 510k Number | K191997 |
| Device Name: | FAICO CMF System |
| Classification | Plate, Bone |
| Applicant | FAICO Medical LLC 9689 Parkview Ave. Boca Raton, FL 33428 |
| Contact | Heman Dario Fernandez |
| Correspondent | Raymond Kelly Licensale Inc 3422 Leonardo Ln New Smyrna Beach, FL 06488 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-26 |
| Decision Date | 2020-04-22 |